Lopid

Product NDC: 0071-0737
11-digit product format: 000710737
Labeler code: 0071
Product ID: 0071-0737_ef2b3c7e-b287-4cae-9bc3-86fb6ccbe9ae
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: gemfibrozil
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Parke-Davis Div of Pfizer Inc
Application: NDA018422
Marketing category: NDA
Marketing start: 2004-03-30
Marketing end: 0000-00-00
Substance: GEMFIBROZIL
Active strength: 600 mg/1
Pharmacologic classes: Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [CS],Peroxisome Proliferator Receptor alpha Agonist [EPC]
NDC exclude flag: No
Listing certified through: 2021-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	0071-0737		D	Discontinued by firm	2026-11-10
excluded package	package	0071-0737	0071-0737-20	D	Discontinued by firm	2026-11-10
excluded package	package	0071-0737	0071-0737-30	D	Discontinued by firm	2026-11-10

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N018422-001	LOPID	GEMFIBROZIL	200MG	CAPSULE / ORAL		Approved before 1982
N018422-002	LOPID	GEMFIBROZIL	300MG	CAPSULE / ORAL		Approved before 1982
N018422-003	LOPID	GEMFIBROZIL	600MG	TABLET / ORAL	AB	RLD, RS	1986-11-20

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
N018422-003	AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 4 · 132 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	N018422-001	LOPID	200MG	CAPSULE / ORAL		Approved before 1982		`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N018422-002	LOPID	300MG	CAPSULE / ORAL		Approved before 1982		`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N018422-003	LOPID	600MG	TABLET / ORAL	AB	RLD, RS	1986-11-20	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N018422-001	LOPID	200MG	CAPSULE / ORAL		Approved before 1982		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N018422-002	LOPID	300MG	CAPSULE / ORAL		Approved before 1982		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N018422-003	LOPID	600MG	TABLET / ORAL	AB	RLD, RS	1986-11-20	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N018422-001	LOPID	200MG	CAPSULE / ORAL		Approved before 1982		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N018422-002	LOPID	300MG	CAPSULE / ORAL		Approved before 1982		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N018422-003	LOPID	600MG	TABLET / ORAL	AB	RLD, RS	1986-11-20	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N018422-001	LOPID	200MG	CAPSULE / ORAL		Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018422-002	LOPID	300MG	CAPSULE / ORAL		Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018422-003	LOPID	600MG	TABLET / ORAL	AB	RLD, RS	1986-11-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018422-001	LOPID	200MG	CAPSULE / ORAL		Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018422-002	LOPID	300MG	CAPSULE / ORAL		Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018422-003	LOPID	600MG	TABLET / ORAL	AB	RLD, RS	1986-11-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N018422-001	LOPID	200MG	CAPSULE / ORAL		Approved before 1982		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018422-002	LOPID	300MG	CAPSULE / ORAL		Approved before 1982		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018422-003	LOPID	600MG	TABLET / ORAL	AB	RLD, RS	1986-11-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018422-001	LOPID	200MG	CAPSULE / ORAL		Approved before 1982		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018422-002	LOPID	300MG	CAPSULE / ORAL		Approved before 1982		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018422-003	LOPID	600MG	TABLET / ORAL	AB	RLD, RS	1986-11-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018422-001	LOPID	200MG	CAPSULE / ORAL		Approved before 1982		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018422-002	LOPID	300MG	CAPSULE / ORAL		Approved before 1982		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018422-003	LOPID	600MG	TABLET / ORAL	AB	RLD, RS	1986-11-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018422-001	LOPID	200MG	CAPSULE / ORAL		Approved before 1982		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018422-002	LOPID	300MG	CAPSULE / ORAL		Approved before 1982		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018422-003	LOPID	600MG	TABLET / ORAL	AB	RLD, RS	1986-11-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018422-001	LOPID	200MG	CAPSULE / ORAL		Approved before 1982		`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018422-002	LOPID	300MG	CAPSULE / ORAL		Approved before 1982		`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018422-003	LOPID	600MG	TABLET / ORAL	AB	RLD, RS	1986-11-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018422-001	LOPID	200MG	CAPSULE / ORAL		Approved before 1982		`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018422-002	LOPID	300MG	CAPSULE / ORAL		Approved before 1982		`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018422-003	LOPID	600MG	TABLET / ORAL	AB	RLD, RS	1986-11-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018422-001	LOPID	200MG	CAPSULE / ORAL		Approved before 1982		`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018422-002	LOPID	300MG	CAPSULE / ORAL		Approved before 1982		`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018422-003	LOPID	600MG	TABLET / ORAL	AB	RLD, RS	1986-11-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N018422-001	LOPID	200MG	CAPSULE / ORAL		Approved before 1982		`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N018422-002	LOPID	300MG	CAPSULE / ORAL		Approved before 1982		`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N018422-003	LOPID	600MG	TABLET / ORAL	AB	RLD, RS	1986-11-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018422-001	LOPID	200MG	CAPSULE / ORAL		Approved before 1982		`79d66fd596c7…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	N018422-003	AB	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N018422-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N018422-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N018422-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018422-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N018422-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018422-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018422-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018422-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018422-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018422-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018422-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N018422-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018422-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018422-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018422-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N018422-003	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N018422-003	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N018422-003	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N018422-003	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N018422-003	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N018422-003	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N018422-003	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N018422-003	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N018422-003	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N018422-003	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N018422-003	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N018422-003	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N018422-003	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N018422-003	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N018422-003	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N018422-003	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N018422-003	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N018422-003	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N018422-003	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N018422-003	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N018422-003	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N018422-003	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N018422-003	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N018422-003	AB	1	`3a93d1ddd44b…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
931dfe50-414f-e1ab-9c88-b15c4ba31929	Product name	5	20210615

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0071-0737-20	Lopid	60 in 1 BOTTLE	TABLET, FILM COATED	60		23
0071-0737-30	Lopid	500 in 1 BOTTLE	TABLET, FILM COATED	500		23

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0071-0737-20	EA - Each	0071-0737	f11b6d36-5e91-47cd-96d0-90580833ef4d	1	2012-07-24
0071-0737-30	EA - Each	0071-0737	e982ed28-ce3b-432c-82e4-381de904fee0	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
gemfibrozil	ACTIVE INGREDIENT	Q8X02027X3	LOPID (GEMFIBROZIL) TABLET, FILM COATED [PARKE-DAVIS DIV OF PFIZER INC]	11
gemfibrozil	ACTIVE MOIETY	Q8X02027X3	LOPID (GEMFIBROZIL) TABLET, FILM COATED [PARKE-DAVIS DIV OF PFIZER INC]	11
CALCIUM STEARATE	INACTIVE INGREDIENT	776XM7047L	LOPID (GEMFIBROZIL) TABLET, FILM COATED [PARKE-DAVIS DIV OF PFIZER INC]	11
CANDELILLA WAX	INACTIVE INGREDIENT	WL0328HX19	LOPID (GEMFIBROZIL) TABLET, FILM COATED [PARKE-DAVIS DIV OF PFIZER INC]	11
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	LOPID (GEMFIBROZIL) TABLET, FILM COATED [PARKE-DAVIS DIV OF PFIZER INC]	11
HYDROXYPROPYL CELLULOSE (TYPE H)	INACTIVE INGREDIENT	RFW2ET671P	LOPID (GEMFIBROZIL) TABLET, FILM COATED [PARKE-DAVIS DIV OF PFIZER INC]	11
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	LOPID (GEMFIBROZIL) TABLET, FILM COATED [PARKE-DAVIS DIV OF PFIZER INC]	11
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	LOPID (GEMFIBROZIL) TABLET, FILM COATED [PARKE-DAVIS DIV OF PFIZER INC]	11
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	LOPID (GEMFIBROZIL) TABLET, FILM COATED [PARKE-DAVIS DIV OF PFIZER INC]	11
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	LOPID (GEMFIBROZIL) TABLET, FILM COATED [PARKE-DAVIS DIV OF PFIZER INC]	11
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	LOPID (GEMFIBROZIL) TABLET, FILM COATED [PARKE-DAVIS DIV OF PFIZER INC]	11
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	LOPID (GEMFIBROZIL) TABLET, FILM COATED [PARKE-DAVIS DIV OF PFIZER INC]	11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0071-0737	LOPID (GEMFIBROZIL) TABLET, FILM COATED [PARKE-DAVIS DIV OF PFIZER INC]	22	Legacy NDC, 2 package rows	20240716_c48855b7-215e-453b-b3b1-a0f9dee7221f.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
Q8X02027X3	GEMFIBROZIL	25812-30-0	GEMFIBROZIL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
310459	gemfibrozil 600 MG Oral Tablet	PSN	c48855b7-215e-453b-b3b1-a0f9dee7221f	23
205751	Lopid 600 MG Oral Tablet	PSN	c48855b7-215e-453b-b3b1-a0f9dee7221f	23
205751	gemfibrozil 600 MG Oral Tablet [Lopid]	SBD	c48855b7-215e-453b-b3b1-a0f9dee7221f	23
310459	gemfibrozil 600 MG Oral Tablet	SCD	c48855b7-215e-453b-b3b1-a0f9dee7221f	23
205751	Lopid 600 MG Oral Tablet	SY	c48855b7-215e-453b-b3b1-a0f9dee7221f	23

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0071-0737-20	00071073720	60 TABLET, FILM COATED in 1 BOTTLE (0071-0737-20)	2004-03-30	0000-00-00	No	No	Current
0071-0737-30	00071073730	500 TABLET, FILM COATED in 1 BOTTLE (0071-0737-30)	2004-03-30	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
LOPID ® (Gemfibrozil Tablets, USP)	Parke-Davis Div of Pfizer Inc \| Pharmacia & Upjohn Company LLC \| Pfizer Inc	2026-05-21	HUMAN PRESCRIPTION DRUG LABEL	23
LOPID ® (Gemfibrozil Tablets, USP)	REMEDYREPACK INC.	2019-06-07	HUMAN PRESCRIPTION DRUG LABEL	3